FDA Grants Priority Review of Biologics License Application for Atacicept in IgA Nephropathy
Atacicept, a dual BAFF/APRIL inhibitor, granted priority review for IgA nephropathy on the strength of trials showing substantial, sustained proteinuria reduction with stabilization of kidney function compared with placebo.
What changed
Atacicept is a TACI-Fc fusion protein that inhibits the immunoregulatory cytokines BAFF and APRIL, which drive B-cell production of galactose-deficient IgA1 central to IgA nephropathy. Its Biologics License Application is supported by the ORIGIN phase 2b program and the pivotal phase 3 ORIGIN 3 trial.
Background
IgA nephropathy is the most common primary glomerulonephritis worldwide, and at least half of patients progress to kidney failure or death within 10 to 20 years. Persistent proteinuria despite maximized renin-angiotensin system inhibition signals high risk, creating a need for disease-modifying therapies that target the underlying B-cell-mediated pathophysiology.
Why it matters
In the phase 3 ORIGIN 3 interim analysis of 203 patients, weekly subcutaneous atacicept 150 mg reduced the urinary protein-to-creatinine ratio by 45.7% from baseline at week 36 versus 6.8% with placebo, a geometric mean between-group difference of about 41.8 percentage points. The earlier phase 2b ORIGIN trial showed proteinuria reduction accompanied by eGFR stabilization, reductions in galactose-deficient IgA1, and improvement in hematuria, with a safety profile similar to placebo and no increase in serious infections. These findings support atacicept as a potential disease-modifying treatment for IgA nephropathy.
Category
Regulatory
Source
FDA
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